Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age
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Purpose
To compare the reactogenicity of ADACEL® vaccine given at intervals of 2 to 9 years with the reactogenicity of ADACEL® vaccine given at an interval of 10 or more years following the last previous administration of vaccine containing Diphtheria and Tetanus Toxoids (referred to as TD/Td).
| Condition | Intervention |
|---|---|
|
Pertussis Diphtheria |
Biological: Tetanus and diphtheria toxoids and acellular pertussis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
- To provide safety information on ADACEL® vaccine given at different time intervals. [ Time Frame: Up to 114 months post-vaccination ] [ Designated as safety issue: Yes ]
| Enrollment: | 7156 |
| Study Start Date: | September 2004 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
18 to 30 months since last prior dose of TD/Td vaccine.
|
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
Other Name: ADACEL®
|
|
2
30 to 42 months since last prior dose of TD/Td vaccine.
|
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
Other Name: ADACEL®
|
|
3
42 to 54 months since last prior dose of TD/Td vaccine.
|
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
Other Name: ADACEL®
|
|
4
54 to 66 months since last prior dose of TD/Td vaccine.
|
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
Other Name: ADACEL®
|
|
5
66 to 78 months since last prior dose of TD/Td vaccine.
|
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
Other Name: ADACEL®
|
|
6
78 to 90 months since last prior dose of TD/Td vaccine.
|
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
Other Name: ADACEL®
|
|
7
90 to 102 months since last prior dose of TD/Td vaccine.
|
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
Other Name: ADACEL®
|
|
8
102 to 114 months since last prior dose of TD/Td vaccine.
|
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
Other Name: ADACEL®
|
|
9
Control - over 114 months since last prior dose of TD/Td vaccine.
|
Biological: Tetanus and diphtheria toxoids and acellular pertussis
0.5 mL, Intramuscular
Other Name: ADACEL®
|
Eligibility| Ages Eligible for Study: | 7 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Children and Adolescents 7 to 19 Years of Age, who have previously recieved Tetanus and Diphtheria Toxoids Vaccine
Inclusion Criteria:
- Age > 7 years and < 20 years.
- Signed and dated IRB-approved informed consent form obtained from the participant, parent or legal guardian prior to the first study intervention.
- Judged to be in good health on the basis of reported medical history.
- Available for planned length of the study.
- Participant or parent or legal guardian (as applicable) can read and write English and can understand the informed consent documents and the study instructions.
A participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the Prince Edward Island public health authorities).
A participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program.
Exclusion Criteria:
- Known or suspected allergy to ADACEL®, any of the vaccine's components, or prior allergic reaction to Diphtheria or Tetanus Toxoids or Acellular Pertussis Vaccine.
- Planned receipt of any other vaccine within the 14 days following administration of ADACEL® vaccine in this study.
- Any other medical condition that in the opinion of the investigator would cause an unexpected hazard or interfere with the study objective.
- Receipt of TD/Td within the preceding 12 months.
- Known or suspected to be pregnant.
A participant eleven years of age or older who meets an exclusion criterion may not be enrolled in the study but nonetheless may participate in the vaccination program, at the discretion of the Prince Edward Island public health authorities).
A participant younger than eleven years of age who meets an exclusion criterion may not be enrolled in the study and may not participate in the vaccination program.
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Medical Monitor, Sanofi Pasteur Inc |
| ClinicalTrials.gov Identifier: | NCT00524732 History of Changes |
| Other Study ID Numbers: | TD511 |
| Study First Received: | September 4, 2007 |
| Last Updated: | October 13, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Sanofi:
|
Pertussis Tetanus Diphtheria |
Additional relevant MeSH terms:
|
Diphtheria Whooping Cough Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections Infection Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013